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ImStem Biotechnology Announces FDA has Lifted the Clinical Hold on the Investigational New Drug Application for IMS001 for the Treatment of Multiple…

By Stell Cell Research

FARMINGTON, Conn., March 20, 2020 /PRNewswire/ --ImStem Biotechnology, Inc. (Farmington CT), a biopharmaceutical company pioneering the development of human embryonic stem cell (ESC) derived mesenchymal stem cells (hES-MSC), through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. We believe this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. The company plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

"As an inventor of our proprietary technology, we look forward to building a company whose foundation lies in our science based upon years of pioneering research," said Dr. Xiaofang Wang, Chief Technology Officer of ImStem Biotechnology.

About IMS001

IMS001 is an investigational, allogeneic, hES-MSC product derived from human embryonic stem cell line. IMS001 has demonstrated preclinical immunomodulatory and blood-brain-barrier (BBB) repair activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs. These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest.

About ImStem Biotechnology

ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured in scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The company's mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. And its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem biotechnology Inc. is a privately held company headquartered in Farmington, CT. For more information, visit http://www.imstem.com.

Media Contact:Investor Relations235411@email4pr.com860-281-7836

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SOURCE ImStem Biotechnology, Inc.

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ImStem Biotechnology Announces FDA has Lifted the Clinical Hold on the Investigational New Drug Application for IMS001 for the Treatment of Multiple...

An unusual chance to see stress at work – Big Think

By Stell Cell Research

It's not your imagination, it turns out. Stress can turn a person's hair gray. It's said that if you look at before and after pictures of any eight-year U.S. president the impact of the office on hair color is clear, though in fairness, it may be that candidates dye their hair and then at some point stop doing so. Nonetheless, scientists from Harvard have not only verified the conventional wisdom on our graying noggins, but have also figured out why stress is so brutal to our follicular pigmentation.

The new research from Harvard scientists is published in the journal Nature.

Image source: Ververidis Vasilis/Evan El-Amin/Vacclav/Shutterstock/Big Think

Senior author of the study Ya-Chieh Hsu, professor of Stem Cell and Regenerative Biology at Harvard, explains what prompted her research:

"Everyone has an anecdote to share about how stress affects their body, particularly in their skin and hair the only tissues we can see from the outside. We wanted to understand if this connection is true, and if so, how stress leads to changes in diverse tissues. Hair pigmentation is such an accessible and tractable system to start with and besides, we were genuinely curious to see if stress indeed leads to hair graying."

It turns out that stress activates nerves associated with our basic fight-or-flight system, and these nerves permanently damage pigment-regenerating melanocyte stem cells in hair follicles, causing them to cease production of melanin that normal provides color to hair follicles.

Hsu's team studied the issue using mice, and was somewhat stunned at their findings. "When we started to study this, I expected that stress was bad for the body but the detrimental impact of stress that we discovered was beyond what I imagined," recalls Hsu.

The scientists stressed the mice using a combination of three methods:

Image source: Helga Lei/Shutterstock

Hsu and her colleagues first suspected an immune system reaction was at the root of graying hairs only to discover that mice without immune systems still turned gray in response to stressors. The next suspect was cortisol produced by the adrenal glands however, this proved not to be so. "Stress always elevates levels of the hormone cortisol in the body," says Jsu, "so we thought that cortisol might play a role. But surprisingly, when we removed the adrenal gland from the mice so that they couldn't produce cortisol-like hormones, their hair still turned gray under stress."

Image source: Judy Blomquist/Harvard University

Finally, the researchers investigate the possibility that the system responding to stressors was the mice's sympathetic nervous systems, the part of the nervous system that kicks into action with the fight-or-flight impulse. The sympathetic nervous system is a vast network of nerves that connects, among other places, to hair follicles in the skin. In response to stress, the system sends a rush of the chemical norepinephrine to the follicles' melanocyte stem cell, causing them to quickly burn through and deplete their stores of pigment.

Say Hsu, "After just a few days, all of the pigment-regenerating stem cells were lost. Once they're gone, you can't regenerate pigments anymore. The damage is permanent." Great for survival, not so good for hair color.

Sympathetic system nerves are magenta above. Melanocyte stem cells are yellow.

Image source: Hsu Laboratory, Harvard University

"Acute stress," says lead author of the study Bing Zhang, "particularly the fight-or-flight response, has been traditionally viewed to be beneficial for an animal's survival. But in this case, acute stress causes permanent depletion of stem cells."

The research, done in collaboration with other Harvard researchers, presents a new appreciation of the effect the sympathetic system can have on the body's cells during stress.

One of these collaborators, Harvard immunologist Isaac Chu, notes, "We know that peripheral neurons powerfully regulate organ function, blood vessels, and immunity, but less is known about how they regulate stem cells. With this study, we now know that neurons can control stem cells and their function, and can explain how they interact at the cellular and molecular levels to link stress with hair graying."

Given this finding regarding the direct impact of stress on follicular stem cells, the question of what it else it may affect becomes an obvious one. As Hsu sums it up, "By understanding precisely how stress affects stem cells that regenerate pigment, we've laid the groundwork for understanding how stress affects other tissues and organs in the body."

This importance of the study therefore goes way beyond graying heads. "Understanding how our tissues change under stress is the first critical step," says Hsu, "toward eventual treatment that can halt or revert the detrimental impact of stress. We still have a lot to learn in this area."

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An unusual chance to see stress at work - Big Think

AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared the Investigational New Drug Application for IMS001 for…

By Stell Cell Research

AgeX Therapeutics, Inc. ("AgeX"; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. (Farmington, CT), a biopharmaceutical company pioneering the development of mesenchymal stem cells (hES-MSC) derived from human embryonic stem cells has received notification from the U.S. Food and Drug Administration (FDA) that it has lifted the hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 was derived from the pluripotential cell line designated ESI-053 licensed from AgeX.

"Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies," stated Dr. Michael D. West, PhD, founder and CEO of AgeX. "This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications."

IMS001 is a formulation of cells derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal cells (hES-MSC) and through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases. IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. ImStem believes this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

"The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created," said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. "As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development."

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly-defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeX is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About IMS001

IMS001 is an investigational, allogeneic, hES-MSC that has undergone IND-enabling, preclinical biodistribution, engraftment, tumorigenicity, toxicology, immunogenicity, and pharmacology studies. IMS001 has demonstrated preclinical immunomodulatory activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs.

Previously published in-vitro data, in collaboration with scientists at the University of Connecticut (UConn) Health, have demonstrated potential advantages of hESC-MSCs in terms of their immunomodulatory effects, as well as the potential to stabilize the blood-brain-barrier (BBB). These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest.

Story continues

About ImStem Biotechnology

ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research by its current founder and Chief Technology Officer Dr. Xiaofang Wang and Dr. Ren-He Xu, former director of UConn Stem Cell Institute, led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured in scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The companys mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. And its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem Biotechnology, Inc. is a privately held company headquartered in Farmington, CT. For more information, visit http://www.imstem.com.

Forward-Looking Statements

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200320005140/en/

Contacts

Media Contact for AgeX:

Bill Douglass Gotham Communications, LLCbill@gothamcomm.com (646) 504-0890

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AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared the Investigational New Drug Application for IMS001 for...

Trail & Tunnel Notes From the Friends of the Old Croton Aqueduc – River Journal Staff

By Stell Cell Research

The Lazy Walkers on the Keepers House porch.Credit: Friends of the Old Croton Aqueduct

Visitors to the Keepers House in Dobbs Ferry often provide stories as intriguing as the house itself, offering a reward to those of us who work as docents there. Here are a sample:

Echoes of Downton Abbey

At four oclock one winter afternoon, I was about to close up when a lone visitor arrived. When I learned that he had come all the way from Astoria, Queens, of course I said, Ill stay open for you. And when I heard his German accent, I couldnt resist a chat to practice my own German. I asked, Was ist ihr Beruf? (What is your profession?) He answered, Ich bin Haushalt Meister. I didnt understand, so he helped me out: Butler to you. I asked, You mean like Carson in Downton Abbey? Yes.

His name is Niklaus. He is, now, as far as I know, the only butler on our membership list.

The Bearded Santa Claus

In early December, a walker arrived who had a long straggly beard, carried a walking stick, backpack, and was wearing sturdy boots and a heavy, well-worn jacket. He deposited himself on a chair, saying he needed a rest. Then to my astonishment he pulled out a wad of hundred dollar bills, saying, I need some maps. He needed $200 worth of maps, To give as Christmas presents.

You must be Santa Claus! I said. He answered, I cant be because Im Jewish, then handed me another hundred dollar bill as a donation.

I learned that he is a mathematician who, as he put it, haunts the halls of MIT.

How Many Walkers Come from Iceland?

So far only two. Recently, an attractive young couple arrived at the House and were fascinated by our story. Of course, I had to get their story. They were doing a short stem-cell research assignment at Sloan Kettering. But how did they find the Keepers House?

The answer was: If you are Scandinavian, or European of any kind, you love to walk. And so you Google Interesting walks. And the Aqueduct pops up. Their explanation made sense; no wonder we get so many European tourists.

The Best-Dressed Bikers in the World

One afternoon, a couple walked in looking as if theyd stepped out of a Gentlemans Quarterly for international bikers, with the correct gloves, shoes and gaiters, and matching vests and helmets.

Recently retired from the medical world in Bremen, Germany, they had flown, with their fancy bikes, to Toronto to bike the Lake Shore and then the Erie Canal. Someone on the Erie Canal route recommended visiting the Keepers House. Thats a hop, skip, and a jump!

While his wife was in the bathroom, the man said to another visitor (from Quebec, as it happens), Dont tell my wife, but Im planning a tour of the Gasp Peninsula in Quebec next year. Well see.

The Trespassers of Decades Ago

Local teenagers had possessed the Keepers House long before we did. We called them our happy trespassers. When we started restoring the broken-down house, we were thrilled to discover, written on the wall of an upstairs room, The Explorers Club. There followed a list of rather childishly written names of neighborhood kids who had hung out in the abandoned house, perhaps climbing in through a cellar window. We took a photograph of the names on the wall before we painted over it. It was as much their house then as it is ours now. I discovered, with a bit of sleuthing, that one of the explorers is still in the neighborhood. I asked if we could take a photo of her and her cousins fellow explorers. She declined, not wanting to be labeled a trespasser. But she understood our pleasure at finding the list before we painted the walls.

The Lazy Walkers

One quiet afternoon, a diverse group of 30 walkers, of various ages, straggled into the House. They obviously needed a rest, having walked almost all the way to Dobbs Ferry from Manhattan. I asked if they were a special group, and they said, We call ourselves The Lazy Walkers. And to think they walked all the way from Manhattan. They said the name gives them permission to dawdle. (But they left the house at a gallop.)

..

I encourage readers to pay a visit to the Keepers House and leave a story behind. And if youd like to be docent, call Mavis at 914-693-0529.

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Trail & Tunnel Notes From the Friends of the Old Croton Aqueduc - River Journal Staff

How Skin Cells Prepare To Heal Wounds – Technology Networks

By Stem Cell Medicine

A team of University of California, Irvine researchers have published the first comprehensive overview of the major changes that occur in mammalian skin cells as they prepare to heal wounds. Results from the study provide a blueprint for future investigation into pathological conditions associated with poor wound healing, such as in diabetic patients.

"This study is the first comprehensive dissection of the major changes in cellular heterogeneity from a normal state to wound healing in skin," said Xing Dai, PhD, a professor of biological chemistry and dermatology in the UCI School of Medicine, and senior author. "This work also showcases the collaborative efforts between biologists, mathematician and physicists at UCI, with support from the National Institute of Arthritis & Musculoskeletal & Skin Diseases-funded UCI Skin Biology Resource-based Center and the NSF-Simons Center for Multiscale Cell Fate Research.

The study, titled, "Defining epidermal basal cell states during skin homeostasis and wound healing using single-cell transcriptomics," was published this week in Cell Reports.

"Our research uncovered at least four distinct transcriptional states in the epidermal basal layer as part of a 'hierarchical-lineage' model of the epidermal homeostasis, or stable state of the skin, clarifying a long-term debate in the skin stem cell field," said Dai.

Using single-cell RNA sequencing coupled with RNAScope and fluorescence lifetime imaging, the team identified three non-proliferative and one proliferative basal cell state in homeostatic skin that differ in metabolic preference and become spatially partitioned during wound re-epithelialization, which is the process by which the skin and mucous membranes replace superficial epithelial cells damaged or lost in a wound.

Epithelial tissue maintenance is driven by resident stem cells, the proliferation and differentiation dynamics of which need to be tailored to the tissue's homeostatic and regenerative needs. However, our understanding of tissue-specific cellular dynamics in vivo at single-cell and tissue scales is often very limited.

"Our study lays a foundation for future investigation into the adult epidermis, specifically how the skin is maintained and how it can robustly regenerate itself upon injury," said Dai.

Reference:Haensel, D., Jin, S., Sun, P., Cinco, R., Dragan, M., Nguyen, Q., Dai, X. (2020). Defining Epidermal Basal Cell States during Skin Homeostasis and Wound Healing Using Single-Cell Transcriptomics. Cell Reports, 30(11), 3932-3947.e6. https://doi.org/10.1016/j.celrep.2020.02.091

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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How Skin Cells Prepare To Heal Wounds - Technology Networks

Physicians Education Resource to Host Live CME Webcast on COVID-19 and Cancer Care – Yahoo Finance

By Stem Cell Medicine

PER is partnering with OncLive for audience generation to ensure all oncologists receive critical information when managing patients with cancer amid this global pandemic

Physicians Education Resource (PER), a leading resource for continuing medical education, in partnership with OncLive for audience generation, will host a live CME-certified 1 hour webcast titled "COVID-19 in Cancer Care: What Oncologists Need to Know Today" that will take place on Monday, March 23, at 8 p.m. EST.

"As the COVID-19 pandemic continues to grow, the care of patients with cancer remains an area of tremendous concern," said Phil Talamo, president of PER. "At its heart, CME is about sharing best practices and expertise to improve patient outcomes, and now is a time where this is more critical then ever. As a leader in oncology education, we feel it is PERs responsibility to quickly host this activity so oncologists can treat patients better at the front line. And we are proud to partner with OncLive, a leading voice in the oncology community, to reach every oncologist."

With nearly 200,000 confirmed cases in the world, according to the World Health Organization as of March 18, the novel coronavirus is a rapidly evolving public health threat. Oncologists are looking for fast, accurate information and guidance to best care for the oncology patients during this pandemic. The webcast will discuss the risk of infection with the coronavirus and severity of illness with COVID-19 across the populations of patients with hematologic and solid tumor malignancies, identify optimal protocols for cancer facilities, in both the inpatient and outpatient settings, to help minimize the risk of coronavirus infection and provide strategies to optimize treatment protocols for patients with cancer in light of the current COVID-19 pandemic.

The featured speakers for this program will be Amelia A. Langston, M.D., professor and executive vice chair, department of hematology and medical oncology, Emory University School of Medicine, director, bone marrow and stem cell transplant program, Winship Cancer Institute of Emory University and medical director, Winship Cancer Network; Ruben A. Mesa, M.D., FACP, director of UT Health San Antonio MD Anderson Cancer Center; Hope S. Rugo, M.D., FASCO, professor of medicine, department of medicine (hematology/oncology), and director, breast oncology clinical trials program, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, and Cardinale Smith, M.D., Ph.D., associate professor of medicine in the department of hematology and medical oncology, associate professor of geriatrics and palliative medicine, Icahn School of Medicine at Mount Sinai.

"We're thrilled to partner with the leading educational provider to leverage the vast OncLive platform to extend PER's reach and provide expert insight during this time of unprecedented concern," added vice president of sales, MJH Life Sciences.

Accredited by the Accreditation Council for Continuing Medical Education and approved by the California Board of Registered Nursing, this live webinar will provide participants the opportunity to earn 1.0 AMA PRA Category 1 Credits and 1.0 nursing contact hour.

For more information and to register, click here.

About Physicians Education Resource (PER)

Since 1995, PER has been dedicated to advancing cancer care through professional education and now advances patient care and treatment strategies on a wide variety of chronic illnesses and diseases. In 2016, PER initiated continuing medical education (CME) programming in the cardiovascular and endocrinology areas. While expanding into topics outside of oncology, PER stands as the leading provider of live, online and print CME activities related to oncology and hematology. The high-quality, evidence-based activities feature leading distinguished experts who focus on the application of practice-changing advances. PER is accredited by the Accreditation Council for Continuing Medical Education and the California Board of Registered Nursing. PER is a brand of MJH Life Sciences, the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels.

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About OncLive

A digital platform of resources for practicing oncologists, OncLive offers oncology professionals information they can use to help provide the best patient care. OncLive is a brand of MJH Life Sciences, the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200320005487/en/

Contacts

PER Media Contact Alexandra Ventura, 609-716-7777, ext. 121aventura@mjhlifesciences.com

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Physicians Education Resource to Host Live CME Webcast on COVID-19 and Cancer Care - Yahoo Finance

A timely Q&A with Bears tight end and ‘resident scientist’ Ben Braunecker – The Athletic

By Stem Cell Medicine

In 2016, the assembled media at Halas Hall met Ben Braunecker, an undrafted rookie tight end out of Harvard. When asked about a post-football career, which is what you ask of a Harvard grad when he enters the league, the molecular and cell biology major said he wanted to be an infectious disease doctor.

Its the brainiac, former Bears tight end Zach Miller said that spring. Infectiousdiseaseguy. So if we have any questions, I go straight to him. Were not shy. Weve already told him that, youre the guy that were coming to if we have questions. Hes working while hes not working. Hes playing football and hes working on his doctor stuff. Were waiting on Harvard shirts as a group. Thats kinda the perk of having the brainiac with us.

With the COVID-19 pandemic gripping the world, Braunecker has been fielding plenty of calls and texts from people in the NFL wanting to get his take. And why not how many football players...

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A timely Q&A with Bears tight end and 'resident scientist' Ben Braunecker - The Athletic

Mesoblast limited (NASDAQ:MESO) Given Consensus Rating of Buy by Brokerages – Redmond Register

By Adult Stem Cells

Mesoblast limited (NASDAQ:MESO) has received an average rating of Buy from the nine brokerages that are presently covering the stock, MarketBeat.com reports. Three equities research analysts have rated the stock with a hold recommendation and five have issued a buy recommendation on the company. The average 12 month price objective among brokerages that have issued ratings on the stock in the last year is $13.83.

Several brokerages recently commented on MESO. Zacks Investment Research downgraded Mesoblast from a buy rating to a hold rating in a report on Tuesday, March 3rd. Maxim Group reiterated a buy rating and set a $16.00 target price on shares of Mesoblast in a report on Friday, February 28th. HC Wainwright reiterated a buy rating and set a $14.00 target price on shares of Mesoblast in a report on Thursday, February 6th. TheStreet upgraded Mesoblast from a d rating to a c- rating in a report on Monday, December 2nd. Finally, Dawson James began coverage on Mesoblast in a report on Thursday, December 19th. They set a buy rating and a $14.00 target price on the stock.

Several large investors have recently made changes to their positions in MESO. M&G Investment Management Ltd. purchased a new stake in shares of Mesoblast during the 4th quarter valued at about $10,440,000. Tobias Financial Advisors Inc. purchased a new stake in Mesoblast during the 4th quarter worth approximately $191,000. Penbrook Management LLC increased its holdings in Mesoblast by 3.9% during the 4th quarter. Penbrook Management LLC now owns 232,100 shares of the companys stock worth $1,711,000 after purchasing an additional 8,800 shares during the last quarter. Finally, Wilbanks Smith & Thomas Asset Management LLC increased its holdings in Mesoblast by 6.0% during the 4th quarter. Wilbanks Smith & Thomas Asset Management LLC now owns 25,025 shares of the companys stock worth $184,000 after purchasing an additional 1,425 shares during the last quarter. Institutional investors and hedge funds own 2.07% of the companys stock.

Mesoblast (NASDAQ:MESO) last released its quarterly earnings data on Wednesday, February 26th. The company reported ($0.23) earnings per share for the quarter, missing the consensus estimate of ($0.20) by ($0.03). The firm had revenue of $2.21 million during the quarter, compared to analyst estimates of $6.54 million. Mesoblast had a negative net margin of 337.18% and a negative return on equity of 15.48%. On average, equities research analysts expect that Mesoblast will post -0.55 EPS for the current fiscal year.

About Mesoblast

Mesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage adult stem cells. The company's products under the Phase III clinical trials include MSC-100-IV for steroid refractory acute graft versus host disease; MPC-150-IM for advanced heart failure; and MPC-06-ID for chronic low back pain due to degenerative disc disease.

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Mesoblast limited (NASDAQ:MESO) Given Consensus Rating of Buy by Brokerages - Redmond Register

Immunotherapy using ‘young cells’ offers promising option against cancer – Washington University School of Medicine in St. Louis

By Stem Cell Medicine

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Study in mouse, human cells suggests unique anti-cancer properties of such a therapy

Pictured is a natural killer (NK) cell that researchers developed in the lab from human pluripotent stem cells. These NK cells mimic the properties of those found in the yolk sac during the earliest stages of development. Such NK cells may be more effective as immunotherapy for cancer treatment than adult NK cells that come from bone marrow, according to a new study from Washington University School of Medicine in St. Louis. White arrows point out granules that contain potent anti-cancer enzymes. Adult NK cells have very few of these granules.

Immunotherapy that involves treating cancer with the bodys own immune cells, or those of a matched donor, shows promise in clinical trials for some patients, but not all.

A new study from Washington University School of Medicine in St. Louis suggests that the age of certain immune cells used in such therapy plays a role in how effective the immunotherapy is. These cells natural killer (NK) cells appear to be more effective the earlier they are in development, opening the door to the possibility of an immunotherapy that would not utilize cells from the patient or a matched donor. Instead, they could be developed from existing supplies of what are called human pluripotent stem cells.

We are trying to improve the effectiveness of immunotherapy for more patients, said senior author Christopher M. Sturgeon, PhD, an assistant professor of medicine. This special source of natural killer cells has the potential to fill some of the gaps remaining with adult NK cell therapy. There is early evidence that they are more consistent in their effectiveness, and we would not need to process cells from a donor or the patient. They could be manufactured from existing cell supplies following the strict federal guidelines for good manufacturing practices. The characteristics of these cells let us envision a supply of them ready to pull off the shelf whenever a patient needs them.

Unlike the adult versions of NK cells used in most investigational therapies, earlier versions of such cells do not originate from bone marrow. Rather, these NK cells are a special type of short-lived immune cell that forms in the yolk sac of the early mammalian embryo. But for therapeutic purposes, such cells do not need to originate from embryos they can be developed from human pluripotent stem cells, which have the ability to give rise to many different cell types, including these specialized natural killer cells. Manufacturing such cells which many academic medical centers already have the ability to do would make them available quickly, eliminating the time needed to process the patients or donors cells, which can take weeks.

The study appears March 19 in the journal Developmental Cell.

Before a certain time point in early development, there is no such thing as bone marrow, but there is still blood being made in the embryo, Sturgeon said. Its a transient wave of blood that the yolk sac makes to keep the embryo going until bone marrow starts to form. And thats the blood cell generation thats making these unique natural killer cells. This early blood appears to be capable of things that adult blood simply cant do.

Studying mouse and human induced pluripotent stem cells that have been coaxed into forming these unique NK cells, the researchers showed that the NK cells are better at releasing specific anti-tumor chemicals a process called degranulation than their adult counterparts. Even NK cells derived from umbilical cord blood do not respond as robustly. NK cells of adult origin also release different chemicals that trigger harmful inflammation, but this response is not necessarily effective against cancer.

Past work by other groups suggested NK cells from earlier development might be more effective, but how and why this was the case remained unknown. The specific origin of these cells was also a mystery.

Now we know where these special natural killer cells come from and that we can never get them from an adult donor, only a pluripotent stem cell, Sturgeon said. Based on their unique behavior alone, there is one small clinical trial of these cells that is ongoing. Now that we know how to manufacture them and how they work, it opens the door for more trials and for improving upon their function.

According to Sturgeon, such cells could be produced from existing lines of pluripotent stem cells that would not need to come from a matched donor because, in general, NK cells do not heavily attack the bodys healthy tissues, as many T cell therapies can. T cells are another type of immune cell often used to treat blood cancer as part of a stem cell transplant, commonly called a bone marrow transplant. Even when NK cells do cause harm, they do not stay in the body for long periods of time.

From a basic science standpoint, Sturgeon also is interested in understanding why these cells are present in the early embryo in the first place and where they go in later development and after birth.

We can only speculate at this point, but its possible that during early embryonic development, when there is so much rapid cell division, these cells are there as a surveillance mechanism to protect against pediatric cancers or infection, he said.

This work was supported by the National Institutes of Health (NIH), grant numbers HL007088-41, R01DK09361, R01CA205239, P50CA171963, 5K12CA167540, and UL1TR002345; an American Society of Hematology Scholar Award; the University of Rochester; the American Cancer Society, grant number IRG-58-010-59-2; the Washington University Center of Regenerative Medicine; the technical expertise of Leah Vit; and the M. Napoleon Memorial Foundation. Electron microscopy was performed at the Washington University Center for Cellular Imaging (WUCCI). Transcriptome analyses were performed at the Genome Technology Access Center (GTAC).

Dege C, Fegan KH, Creamer JP, Berrien-Elliott MM, Luff SA, Kim D, Wagner JA, Kingsley PD, McGrath KE, Fehniger TA, Palis J, Sturgeon CM. Potently cytotoxic natural killer cells initially emerge from erythro-myeloid progenitors during mammalian development. Developmental Cell. March 19, 2020.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Immunotherapy using 'young cells' offers promising option against cancer - Washington University School of Medicine in St. Louis

The personal and economic burden of traumatic brain injury – Eagle & Times

By Stem Cell Medicine

(BPT) - It could be due to a car accident. It might be attributed to an injury at work. It might be the result of a simple fall. Traumatic brain injury can happen to anyone of any age, and it's probably more common than you think.

What is traumatic brain injury (TBI)?

A TBI is often caused by a bump, blow or jolt to the head that disrupts the normal function of the brain, according to the Centers for Disease Control and Prevention. Severity of TBI can be mild and temporary or severe and life altering. In the worst cases, a person can die from a TBI.

The number of TBI-related emergency department visits, hospitalizations and deaths has increased by 53% and an average of 155 people in the U.S. die every day from injuries that include a TBI, according to CDC data from 2006-2014. There is an estimated $80 billion in lifetime costs within the U.S. alone related to TBI.

"People who experience and survive a TBI often suffer from numerous other health conditions as a result, including headaches, memory loss, anxiety and depression, sleep deprivation, epilepsy and even alcohol or drug abuse," said Dr. Ramon Diaz-Arrastia, Professor of Neurology and Director of Clinical TBI Research at the University of Pennsylvania. "Concussions in sports have helped bring the frequency of TBIs to light, but there's still so much work to do because everyone is impacted by this condition either directly or indirectly."

Who is impacted most by TBIs?

Research shows TBI disproportionately affects vulnerable populations. For example, recent peer reviewed research shows that 53% of homeless people have suffered from TBI, according to health journal "The Lancet Public Health." Additionally, more than 65% of prisoners and 75% of women experiencing domestic violence have suffered from TBI, according to the "Journal of Neurotrauma."

People in the military are more susceptible to TBI. Concussions have been capturing headlines for athletes, who also are at high risk of experiencing a TBI. It's a leading cause of disability and death in children. When someone experiences this type of injury, their life can be forever altered. It also impacts their family as well as society as a whole, as some cannot continue to work, care for a home or even properly care for themselves without assistance.

The need for research and new treatments

"To better address this public health issue, we must create a national registry that will provide critical information to help move forward the medical treatment of individuals with TBI so we can improve their care and research new treatments," said Dr. Stephanie Kolakowsky-Hayner, President Elect, American Congress of Rehabilitation Medicine.

She is joined by leading TBI organizations like the Brain Injury Association of America and the Congressional Brain Injury Task Force to call for action from The Department of Health and Human Services (HHS) to create this type of national registry. The current system is decentralized and relies on states and regions to construct their own registries, leaving millions of people without resources to manage their TBI. The goal is to develop a single, standardized level of care for individuals living with TBI nationwide.

A comprehensive registry would also facilitate more clinical trials, which could advance the treatment of people with TBI. One treatment showing promising initial results is a regenerative cell medicine (SB623) composed of stem cells that are implanted around the injured area. Focused on improving chronic motor deficiency, the Phase II data last year reported the effectiveness of the treatment that may regenerate brain cells following a TBI.

To learn more about TBI visit http://www.cdc.gov. To learn about research and efforts being made to advance a national registry, visit http://www.biausa.org.

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The personal and economic burden of traumatic brain injury - Eagle & Times

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